RU2564078C2 - Intravaginal device for enuresis treatment - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to intravaginal devices for the treatment of enuresis from a flexible polymeric material. An intravaginal device has an end for introduction and an opposite end for its bringing out and contains a flexible frame, which includes a working part and a fixing part. The working part is placed in immediate vicinity to the end for bringing out and contains a flexible construction, which has a multitude of connected elongated elements, located and made with a possibility to determine opposite work surfaces to provide support for the urinary system. The fixing part is placed in immediate vicinity to the end for introduction, projects beyond the limits of the working part and contains a multitude of connected elongated elements, located and made with a possibility of extension in the side direction inside the user's vagina. The elongated elements contain a high-modulus polymer with the elasticity modulus of at least 2 HPa and initial tension at 3% stretching of at least about 30 MPa. In the second version of the intravaginal device implementation the working part contains a multitude, in fact, longitudinally oriented, elongated connected to each other bars. The bars have opposite working surfaces, which provide support for the urinary system; and an equivalent diameter in introduction in the range from approximately 5 to approximately 25 mm and the length in the range from approximately 20 to approximately 60 mm. The device contains a high-modulus polymer, which has the elasticity modulus of at least 3 HPa and the cycle symmetry coefficient higher than approximately 0.5. In the third version of the intravaginal device implementation the elongated elements contain a high-modulus polymer with the elasticity modulus of at least 2 HPa and the cycle symmetry coefficient higher than approximately 0.7. In the fourth version of the intravaginal device implementation the elongated elements contain a high-modulus polymer with the elasticity modulus of at least 2 HPa and fatigue stress (t=50 hours and 40°C) at 3% extension of at least approximately 30 MPa.

EFFECT: inventions are very elastic and resilient and can be produced by a reliable and economical method.

22 cl, 6 dwg, 2 tbl

Description

FIELD OF THE INVENTION

This invention relates to intravaginal devices for the treatment of urinary incontinence from an elastic polymer material. In particular, this invention relates to devices whose working part has a variable equivalent diameter, length that allows the device to be inserted into the vagina, a mechanism for intravaginal fixation, and is made of high-modulus polymers with a high tensile modulus and high tensile at yield strength. In addition, these polymers have creep resistance and stress relaxation. The device can be used to reduce or prevent stress urinary incontinence.

DESCRIPTION OF THE known level of technology

Stress urinary incontinence is a problem for many women. It is characterized by leakage of urine during exertion, such as coughing or sneezing. To reduce or prevent stress urinary incontinence, many devices have been created. Tutrone, Jr., US Patent No. 5,603,685, discloses the invention of inflatable devices that could be small in size when inserted into the vagina and there take the desired shape and exert the necessary pressure to reduce or prevent urinary incontinence. Zunker et al., US Pat. No. 6,090,098, teaches the invention of tampon-like devices that were made from a combination of absorbent / or non-absorbent fibrous materials. Ulmsten et al., US Patent No. 6,645,137, discloses the invention of a spiral that can expand into the vagina. Biswas, US Patent No. 5036867, discloses the invention of a compressible elastic pessary. James, US Patent No. 6,460,542, teaches the invention of a rigid pessary of a particular shape. Many patents provide descriptions of stents that have been designed and sized so that with their help, the lumen of the arteries remains open.

U.S. Patent Pending Application No. 2008/0009664 (Bartning et al.) Teaches the invention of devices for treating urinary incontinence, which can be made from shape memory polymers that can be defined as materials that an initial form can be given, which can then be converted into a stable additional form. When exposed to the appropriate factor, the material is actually able to return to its original form. Along with materials with shape memory, this publication discusses elastic or highly elastic materials represented by metal alloys such as nitinol, linear block copolymers undergoing phase separation, biostable or biologically absorbable shape memory polymers (PPF), etc. PPF can also be obtained from thermoplastic elastomers made from hydrophilic polymers. These elastomers are usually low modulus polymers, so they may or may not be able to significantly stretch before breaking.

Despite the messages characterizing the prior art, there is still a need for devices designed for insertion into the vagina, which can be used to reduce or prevent stress urinary incontinence. Such a device must be very flexible and resilient.

SUMMARY OF THE INVENTION

We have invented an intravaginal device for the treatment of urinary incontinence, which can be used to reduce or prevent stress urinary incontinence and can be manufactured in a reliable and economical way. We have found that we can produce a very resilient polymer device that meets the needs of women suffering from stress urinary incontinence.

In one embodiment of the present invention, an intravaginal device for treating urinary incontinence has an end for administration and an opposite end for excretion of the device. The device comprises an elastic frame including a working part located in close proximity to the end for withdrawal, and a fixing part located in close proximity to the end for introducing the device. The working part comprises a plurality of connected and substantially longitudinally oriented elongated elements, namely, an elastic structure having a plurality of connected elongated elements arranged and configured to define opposed working surfaces to provide support for the urinary system. The locking part extends beyond the working part and has many associated elongated elements located and configured to expand laterally inside the vagina of the user. The elongated elements comprise a high modulus polymer having an elastic modulus of at least 2 GPa and an initial stress at 3% elongation of at least about 30 MPa. Preferably, in this embodiment of the present invention, the high modulus polymer has an elongation at the yield strength of at least 3%, a cycle asymmetry coefficient of at least about 0.5, and / or stress after aging (t = 50 hours at 40 ° C) at 3% elongation of more than 35 MPa.

In another embodiment of the present invention, the intravaginal device for treating urinary incontinence has an end for administration and an opposite end for the excretion of the device. The device includes a working part located in close proximity to the end for withdrawal, and a fixing part located in close proximity to the end for introducing the device. The working part has many interconnected beams having opposite working surfaces that support the urinary system, which, when introduced, have an equivalent diameter in the range of 5 to 25 mm and a length in the range of 10 to 60 mm. The fixing part extends beyond the working part, and this device contains a high-modulus polymer having an elastic modulus of at least 3 GPa and a cycle asymmetry coefficient of more than 0.5. Preferably, in this embodiment of the present invention, the high modulus polymer has a relative elongation at the yield strength of at least 3% and / or fatigue stress (t = 50 hours at 40 ° C) at 3% elongation of more than 35 MPa.

In another embodiment of the present invention, the intravaginal device for treating urinary incontinence has an end for administration and an opposite end for the excretion of the device. The device includes a working part located in close proximity to the end for withdrawal, and a fixing part located in close proximity to the end for introducing the device. The working part has many connected beams having opposite working surfaces, providing support for the associated urinary system. The fixing part extends beyond the working part, and this device contains a high-modulus polymer having an elastic modulus of at least 2 GPa and a cycle asymmetry coefficient of more than 0.7. Preferably, in this embodiment of the present invention, the high modulus polymer has a relative elongation at the yield strength of at least 3%, and / or stress after aging (t = 50 hours at 40 ° C), with a 3% elongation of more than 35 MPa.

In yet another embodiment of the present invention, an intravaginal device for treating urinary incontinence has an end for administration and an opposite end for excretion of the device. The device includes a working part located in close proximity to the end for withdrawal, and a fixing part located in close proximity to the end for introducing the device. The working part has many interconnected beams having opposite working surfaces, providing support for the urinary system. The fixing part extends beyond the working part, and this device contains a high-modulus polymer having an elastic modulus of at least 2 GPa and stress after aging (t = 50 hours at 40 ° C) at 3% elongation of more than 30 MPa. Preferably, in this embodiment of the present invention, the high modulus polymer has an elongation at a yield strength of at least 3%, stress after aging (t = 50 hours at 40 ° C) at 3% elongation of more than 35 MPa.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1. Front view of the device in accordance with the present invention.

FIG. 2. Perspective view of an embodiment of the present invention.

FIG. 3 Front view of the embodiment of FIG. 2.

FIG. 4. Side view of the embodiment of FIG. 2.

FIG. 5. Front view of the embodiment of FIG. 2. compressed in assembled condition.

FIG. 6. The anatomical cross section of a woman using the embodiment of FIG. 2.

DESCRIPTION OF THE INVENTION

The problem that developers of intravaginal devices for the treatment of urinary incontinence have encountered and continue to face is the development of an effective, reliable polymer device with a small cross section for relatively easy administration. At the same time, there remains a need for stiffness of the device, which could exert pressure on the walls of the vagina to provide the necessary support for the bladder and other organs of the female urinary system. The materials used in the well-known descriptions of inventions include elastic or highly elastic materials represented by metal alloys such as nitinol, linear block copolymers that have undergone phase separation, biostable or biologically absorbable shape memory polymers (PPF), etc. However, these materials are either expensive or not sufficiently resilient, rigid or elastic for the required operating conditions, or have several of these disadvantages.

We found that it is difficult to find a balance between the elasticity of the material of which the device is composed and its ability to reduce its cross section to ensure easy insertion. Therefore, it is advisable to consider the elasticity and stiffness of these materials. If the material used in the manufacture of the device is too rigid, it will be difficult to compress it to give the device the necessary configuration, due to which it can be placed in the applicator of a much smaller diameter.

The term “high modulus polymer” as used herein and its variants refer to polymers having a high tensile modulus and high tensile strength. Materials made from such polymers have high viscosity and high impact strength.

In the context of the description and claims, the term “stent” and its variants as used herein refers to a device that is used to maintain expanded openings of body openings, cavities, vessels, and the like. The stent must be resilient, flexible, compressible and have shape memory. The stent may be of any suitable shape, including, but not limited to, mesh, wire, or the form of a split tube.

Suitable forms of the devices of the present invention have been listed in the appendix to US Patent No. 2008/0009664, the entire disclosure of which is incorporated herein by reference. Referring to Figure 1, in accordance with the present invention, there is shown a device 10. The device 10 has an end for insertion 12 and an end for output 14. The device includes an external flexible stopper, such as a pessary 16, containing an elastic frame, such as a stent, and an element for outputting the device represented by the thread 18.

In one embodiment of the present invention, the flexible sheath 16 comprises a resilient framework shown in FIGS. 2-5. The elastic frame 20 includes a fixing part 22 located in close proximity to the end for insertion 12, and a working part 24 located in close proximity to the end for withdrawal 14. The working part 24 has surfaces 26a and 26b. The working part 24 has an initial equivalent diameter di ranging from 20 mm to 170 mm and a length L ₁ ranging from 15 mm to 60 mm. Since the working part does not have the shape of a cylinder, the equivalent diameter represents the maximum distance in millimeters between its opposite surfaces. As can be seen from Figure 5, the working part 24 has an equivalent diameter when introducing d ₂ (in the applicator 28 or other device for the introduction), which varies from 5 mm to 20 mm As can be seen from Fig.6, the working part 24 has an equivalent diameter when using (in the vagina) d ₃ , which varies from 5 mm to 40 mm

The working part 24 contains a high-modulus polymer structural material, which is compressed and restores its original shape with sufficient strength to provide the desired effect. Such high modulus polymers have an elongation at a yield strength of at least 3% and an elastic modulus of at least 2 GPa. A representative but not exhaustive list of suitable high modulus polymers includes thermoplastic materials, thermosetting materials, fiber-filled polymers, polyetherimide, polyetheretherketone, polycarbonate, copolymers, specialized and / or modified plastics, filled plastics, and the like, which can provide these high modulus properties. High modulus polymers, including polyetherimides and polyether ether ketones, are particularly preferred.

Thus, high-modulus polymers have a high modulus of elasticity in tension and high tensile strength. Preferably, the polymer has a tensile modulus or an elastic modulus of at least 2 gigapascals (GPa). In addition, it is preferable that this polymer has a high tensile strength at the yield strength or elongation at the yield strength of at least 3%, more preferably elongation at the yield strength of at least 4.5% and most preferably elongation at the yield strength of at least 5% . It is also preferred that the high modulus polymer is capable of resistance to creep and stress relaxation.

In one embodiment of the present invention, the working part 24 includes a plurality of connected elongated elements, such as beams 30. One or more of these elongated elements 30 must directly or indirectly connect the working part 24 to the fixing part 22. Longitudinal view of the elongated elements of the working part of the device determines the length of the working part L ₁ . The working pressure applied by the working part 24 is determined, in particular, by the selected material with a high modulus of elasticity and the parameters of the elongated elements. Thicker and / or shorter elongated elements usually exert greater working pressure. In addition, the angle between the elongated elements also affects the working pressure.

The elongated elements 30 have a much smaller diameter than the diameter of the working and / or fixing part. Preferably, the elongated elements have a diameter of less than 5 mm, more preferably within 1 mm to 4 mm, most preferably within 1.5 mm to 3 mm. If the diameter of the elongated elements is too large, the device will become too rigid and too large to be properly compressed to allow easy insertion. If the diameter is too small, the device will not be able to exert sufficient pressure to provide support for the associated urinary system.

To perform certain functions, the working part in the following way, when expanding, is capable of applying a force of 2 to 8 Newton (N) in working condition, preferably from 2 to 6 N, and most preferably from 3 to 6 N.

The frame 20 also has a locking portion 22. The locking portion 22 has a suitable shape that allows it to hold the device 10 in place during use. Suitable forms include, but are not limited to, the shapes of baskets with handles, canine bone, wings and rabbit ears. The locking part 22 may contain the same material as the working part 24, or they can be made of different materials. The working part 24 and the fixing part 22 can be made in the form of a single structure, or can be manufactured separately and then connected by fastening. To improve biocompatibility, the frame 20 must undergo a special treatment. To improve biocompatibility and / or comfort, the frame 20 can be partially or entirely enclosed, for example, by enclosing the device in a tube, coating, pressing, etc. The embodiment of the present invention in FIGS. 2-5 shows that the frame 20 is coated with an outer layer of material 32 (in FIG. 2, the outer layer 32 has been removed to demonstrate the frame 20).

The devices of the present invention can be used to treat or prevent stress urinary incontinence. For these purposes, the device should be sized so that it can comfortably fit in the vagina. The devices described below have working parts with initial equivalent diameters from 20 to 170 mm. Preferably, the working part has an initial equivalent diameter in the range of from about 20 to 170 mm, preferably from about 20 to 45 mm, or, more preferably, about 30 mm; the equivalent diameter upon administration should vary from about 5 to 25 mm, preferably from 10 to 20 mm, or more preferably about 18 mm; the equivalent diameter when used should vary from about 10, 20 to 40 mm, preferably from about 25 to 30 mm, or, more preferably, about 25 mm; and the length should vary from about 20 to 60 mm, preferably from about 20 to 30 mm, or, more preferably, about 25 mm.

The locking portion extends beyond the working portion away from the vaginal opening and should have an initial equivalent diameter in the range of about 30 to 200 mm, preferably about 40 to 60 mm, or more preferably about 50 mm; the equivalent diameter during administration should vary from about 10 to 25 mm, preferably from about 10 to 20 mm, or, more preferably, about 18 mm; the equivalent diameter when used should vary from about 20 to 100 mm, preferably from about 40 to 60 mm, or, more preferably, about 50 mm; and the length should vary from about 10 to 50 mm, preferably from about 20 to 40 mm, or, more preferably, about 30 mm.

The fixing part of the device has a certain length and width during insertion, in operation and during withdrawal. The length of the device during administration can vary from about 25 to 40 mm, and be, for example, about 30 mm. The width of the device during administration can vary from about 10 to 20 mm, and be, for example, about 18 mm. In working condition, the length of the device at rest and when coughing can vary from about 25 to 40 mm and, for example, be about 30 mm. In working condition, the width of the device at rest and when coughing can vary from about 15 to 35 mm and, for example, be about 30 mm.

As shown in figure 1, the frame 20 can be placed in a flexible shell 16, like in a bag, which can reduce friction during expansion of the device, make the frame 20 invisible (so that the device looks aesthetically pleasing), helps to control the device 10 during insertion and excretion, helping to fix it in place and / or creating more contact areas for transferring pressure to the neck of the bladder. The flexible sheath 10 16 can also increase friction in contact with the vaginal epithelium to reduce the likelihood of unwanted movements of the device during use, for example, its displacement. For the manufacture of a flexible shell, any medically acceptable materials may be used, and, depending on the desired end use, this material should be opaque, light and / or breathable. Materials suitable for the manufacture of a flexible sheath include those used in the manufacture of tampons, such as a non-woven fabric and a polymer film, including a perforated film. The sheath itself can also be perforated. In one embodiment of the present invention, the frame was placed in a bag with seams around the perimeter, which was made of non-woven polypropylene material used in coatings of intravaginal tampons. The frame in the shell can be easily removed using the element for output 18, represented by the usual thread of the tampon.

The element for the withdrawal 18 can be stretched between the tension elements 30 of the frame 20 to create a device like “pouch”. For this purpose, any thread or fabric used at this level of technology for the production of feminine hygiene products can be used. When the thread is tensioned during the removal of the device, the compressed tension elements approach each other, so that during the removal of the device, its diameter becomes smaller. Pulling the device to its base can make its removal easier and more comfortable, as its diameter is reduced, and this form makes it easier to remove.

As shown in FIG. 5, the device 10 may be located inside the applicator 28, similar to the applicators used to administer tampons and suppositories. The applicator can be push or pull. A limiter ring may be added to control the depth of insertion.

The resilient carcass 20 can be made by any known polymer production technique. Preferably, the carcass was obtained by injection molding, and from the point of view of manufacturability in these systems can be selected high modulus polymer. The elastic cage 20 may then be coated or it may be enclosed by known means.

EXAMPLES

The following examples demonstrate devices in accordance with the present invention. The claims should not be limited to the details described below.

Expansion Force Test

The external force exerted by the polymer skeleton on various compressible areas was measured using an Instron universal tensile strength testing machine (Model 1122, Instron Corp., Canton, Mass.) In a room at 23 ° ± 2 ° C. The universal testing machine was equipped with two opposing rigid horizontal plates. One plate was attached to the guide head. Another plate was facing the first and attached to the upper fixing surface. To compress the sample, the lower plate moved upward along with the guide head. Both opposing plates were rigid, and were made of aluminum or steel. The upper plate was attached to a voltage sensor designed to measure compressive forces in the range from 0 to 30 Newton (N).

To start the test, the plates were installed at an initial distance of 37 mm from each other. Either before or after aging, two sides of the working part of each device should be placed between these plates. If the working part of the device is cylindrical, then opposite sides of the cylinder come into contact with the plates. In non-cylindrical devices, the front and rear sides must contact the plates. Due to the movement of the guide head, the plates moved towards each other at a speed of 25.4 mm / min, until the distance between them reached 10 mm. The force measured by the voltage sensor when the plates approach each other was recorded automatically. The registered measurement is the expansion force at a distance between the plates of about 20 mm. At the initial time (the sample was not subjected to storage), the devices were not in the applicator. To determine the properties of the device at a time corresponding to 5 minutes of storage, each device was tested after being placed in an applicator with an internal diameter of 15.6 mm for 5 minutes at room temperature. To determine the properties of the device at the final moment of time, each device was placed in an applicator with an internal diameter of 15.6 mm and stored in it for three weeks at 40 ° C. After a predetermined time, the device was removed from the applicator and left to cool to room temperature for 15-30 minutes. For each moment in time, n = 3. The results are shown in Table 1.

Note: The applicator has an internal diameter of 15.6 mm and an external diameter of 18 mm. It was made by injection molding from polyethylene. These parameters and materials were chosen to minimize deformation during storage.

Table 1 Sample
No. Trade Name, Code, Supplier Species designation The expansion force (N) at 20 mm t = 0 (the sample was not subjected to storage) Expansion force (N) at 20 mm t = 5 min (storage at 23 ° C) Expansion force (N) at 20 mm t = 3 weeks (storage at 40 ° C) one Ultem®1010, SABIC Americas, Inc (Houston, TX) Polyetherimide 8.24 8.38 4.77 2 Victrex® 450G Victrex USA Inc. (West Conshohocken, PA) Polyether ether ketone 7.06 7.53 4.89 3 Profax SR549 Basell North America, Inc., Wilmington, Delaware Polypropylene 2.48 1.82 0.13 four Cycolac MG47 SABIC Americas, Inc (Houston, TX) Acrylonitrile Butadiene Styrene 5.87 4.34 0.01 5 Petrothene NA831 Basell North America, Inc., Wilmington, Delaware Low density polyethylene 0.41 0.36 0.04 6 Caliber 2061 Dow, Inc., Midland, MI Polycarbonate 5.66 5.16 1.45

As shown in Table 1 above, for some polymers, there was a significant lack of expansion force, which manifested itself in a sharp decrease over time compared with the initial time point. After 3 weeks of storage at 40 ° C, devices of only two materials apparently retained their expansion properties with a strength of at least 2 N. This indicates that devices made of materials with low creep retain their expansion properties and able to exert sufficient pressure when placed in the vagina.

Preferred materials that have retained their expanding properties with a force greater than 1 N include polycarbonate, polyetheretherketone and polyetherimide. At the same time, it is clear that during prolonged storage, polycarbonate substantially loses its expandability, and therefore polyetherimide and polyether etherketone have more desirable properties.

To determine the basic properties of the material, which could indicate its ability to expand sufficiently after long-term storage, additional tests were carried out on a set of samples of materials from Table 1, which were used for the manufacture of devices. Tested material properties included modulus of elasticity, tensile strength and stress relaxation.

The modulus of elasticity and tensile strength were determined using the methodology of the American Society for Testing Materials (ASTM) D638-2008, which was published on February 6, 2009. An ASTM Type I tensile test specimen with a thickness of about 3 mm was used. Actual thickness was measured and included in the calculation. The sample was aged before testing for 40 hours at 23 ° C and 50% relative humidity (“RH”), and was tested at 23 ° C and 49% RH. The speed of the guide head was 5 mm / min. The elastic modulus (in gigapascals, GPa) was obtained by calculating the slope of the linear regression graph of the experimental points of the curve of the dependence of the conditional stress on conditional tension in the interval between 0.05 and 0.25% tension. Elongation at yield strength was calculated as the stress at the peak stress concentration point on the curve of conditional stress versus conditional tension. A non-contact extensometer was used for all tensile measurements.

The stress relaxation test was carried out on a Instron universal tensile strength test machine (electromechanical model 5582) with a temperature-controlled chamber for environmental testing. The ASTM Type I tensile strength test materials (approximately 3 mm thick) were stretched at a speed of 5 mm / minute with a non-contact extensometer to measure the tensile stress in the standard central part of the workpiece. These data were used to determine the initial load required to obtain a 3% elongation in the standard central portion of the workpiece. New samples were subjected to a design load while measuring tensile strength with an extensometer. Over a 50-hour period, the guide head was automatically adjusted to maintain 3% elongation in the central part of the workpiece, at the same time, the applied load was monitored and the stress was calculated. To determine the "Stress after aging" stress (megapascals, MPa) was calculated as the applied load divided by the initial cross-sectional area of the sample in the standard central part. And finally, the “Cycle Asymmetry Coefficient” is expressed as a percentage of the stress after aging to the initial stress.

The test results of these materials are shown below in Table 2.

table 2 Sample
No. Trading
title Module
resilience
(GPa) Elongation at yield strength (%) Stress relaxation (stress at 3% strain) Initial stress (t = 0) (MPa) Stress after aging (t = 50 hours at 40 ° C) (MPa) Coefficient
cycle asymmetries one Ultem®
010 3.6 6.95 91.08 50.57 0.56 2 Victrex®
450g 4.4 5.17 81.60 59.00 0.72 3 Profax
SR549 1.3 12.09 19.40 6.40 0.33 four Cycolac
MG47 2,4 2.27 35,20 11.30 0.32 5 Petrothene
NA831 0.3 100.26 3.40 1.70 0.50 6 Caliber
2061 2,4 6.01 52.90 32,20 0.61

As shown in Tables 1 and 2, not all polymers have a suitable modulus of elasticity, elongation at yield strength and stress relaxation. The combination of these properties allows you to choose materials that have the necessary parameters for the manufacture of a polymer device with high elasticity, which would meet the needs of women suffering from urinary incontinence.

Therefore, the comparison of the properties of materials given in the table indicates that these materials have relatively limited stress relaxation, and those materials that have a relative strength of more than 50% can be used in the present invention.

As a result, the materials used must have an elastic modulus of at least about 2 GPa, preferably at least about 3 GPa. The elongation at yield strength should be at least about 2%, preferably at least about 3%, and most preferably at least about 5%. The initial stress (t = 0 hours) at 3% elongation is at least about 30 MPa, preferably at least about 50 MPa, and most preferably at least about 80 MPa. The stress after aging (t = 50 hours at 40 ° C.) at 3% elongation is at least about 30 MPa, preferably at least about 35 MPa, and most preferably at least about 50 MPa. As a result, the coefficient of asymmetry of the cycle should be at least about 0.5, preferably at least about 0.7, and most preferably at least about 0.8.

In one preferred embodiment of the present invention, the device consists of a material having an elastic modulus of at least about 2 GPa and an initial stress of at least about 30 MPa at 3% elongation. More preferably, the device has an elongation at a yield strength of at least about 3%.

In another preferred embodiment of the present invention, the device consists of a material having an elastic modulus of at least about 3 GPa and a cycle asymmetry coefficient of at least about 0.5. More preferably, the device has a relative elongation at a yield strength of at least about 3%, and stress after aging (t = 50 hours at 40 ° C) at 3% elongation of at least about 35 MPa, and more preferably at least about 50 MPa.

In another preferred embodiment of the present invention, the device consists of a material having an elastic modulus of at least about 2 GPa and a cycle asymmetry coefficient of at least about 0.7. More preferably, the device has a relative elongation at a yield strength of at least about 3%, and stress after aging (t = 50 hours at 40 ° C) at 3% elongation of at least about 35 MPa.

In another preferred embodiment of the present invention, the device consists of a material having an elastic modulus of at least about 2 GPa and a stress after aging (t = 50 hours at 40 ° C) at 3% elongation of at least about 30 MPa, and more preferably at least about at 50 MPa. In addition, the material of the present invention should have a relative elongation at a yield strength of at least about 3%.

The specification and implementations described above are presented to facilitate a complete and unrestricted understanding of the described invention.

Since many changes and embodiments of the invention can be carried out without violating its essence and subject matter, the invention lies in the following applications.

Claims (22)

1. An intravaginal device for treating urinary incontinence, having an end for injection and an opposite end for its excretion, where the specified device contains an elastic frame, including:
a working part located in close proximity to the end for excretion, which contains an elastic structure having a plurality of connected elongated elements located and configured to define opposing working surfaces to provide support for the urinary system;
and a fixing part located in close proximity to the end for insertion and protruding beyond the working part, which contains many connected elongated elements located and configured to expand laterally inside the vagina of the user,
where the elongated elements contain a high modulus polymer with an elastic modulus of at least 2 GPa and an initial stress at 3% elongation of at least about 30 MPa. 2. The device according to claim 1, in which the high modulus polymer has an elongation with a yield strength of at least 3%. 3. The device according to claim 1, in which the modulus of elasticity is at least 3 GPa and the asymmetry coefficient of the cycle is at least about 0.5. 4. The device according to claim 1, in which the stress after aging (t = 50 hours at 40 ° C) at 3% elongation is more than about 35 MPa. 5. The device according to claim 1, in which the high modulus polymer is selected from the group comprising polyetherimides, polyether ether ketones, and combinations thereof. 6. The device according to claim 1, in which the working part contains many connected and essentially longitudinally oriented elongated elements. 7. The device according to claim 6, in which the working part has a length in the range from about 10 to about 50 mm. 8. An intravaginal device for the treatment of urinary incontinence, having an end for administration and an opposite end for its excretion, where the specified device contains:
a) a working part located in close proximity to the end for removal, which contains a lot of essentially longitudinally oriented, elongated, interconnected beams having:
i) opposed countertops supporting the urinary system; and
ii) an equivalent diameter when introduced in the range of from about 5 to about 25 mm and a length in the range of from about 20 to about 60 mm; and
b) a fixing part located in close proximity to the end for insertion and protruding beyond the working part;
however, the device contains a high-modulus polymer having an elastic modulus of at least 3 GPa and a cycle asymmetry coefficient of more than about 0.5. 9. The device according to claim 8, in which the high-modulus polymer has an elongation at the yield strength of at least 3% and stress after aging (t = 50 hours at 40 ° C), with a 3% elongation of at least about 35 MPa. 10. The device according to claim 9, in which the stress after aging (t = 50 hours at 40 ° C) at 3% elongation of at least about 50 MPa. 11. The device according to claim 8, in which the high modulus polymer is selected from the group comprising polyetherimides, polyether ether ketones, and combinations thereof. 12. The device according to claim 8, in which the working part contains many connected and essentially longitudinally oriented elongated elements. 13. The device according to p. 12, in which the working part has a length in the range from about 10 to about 50 mm 14. An intravaginal device for the treatment of stress urinary incontinence, having an end for insertion and an opposite end for its excretion, the device comprising an elastic frame, including:
a working part located in close proximity to the end for withdrawal, which contains an elastic structure having a plurality of connected elongated elements located and configured to determine opposed working surfaces to provide support for the urinary system;
and a fixing part located in close proximity to the end for insertion and protruding beyond the working part, which contains many connected elongated elements located and configured to expand laterally inside the vagina of the user,
where the elongated elements contain a high modulus polymer with an elastic modulus of at least 2 GPa and a cycle asymmetry coefficient of at least about 0.7. 15. The device according to p. 14, in which the high-modulus polymer has a relative elongation at the yield strength of at least about 3% and stress after aging (t = 50 hours at 40 ° C) at 3% elongation of at least about 35 MPa. 16. An intravaginal device for the treatment of stress urinary incontinence, having an end for injection and an opposite end for its excretion, while the device contains an elastic frame, including:
a working part located in close proximity to the end for withdrawal, which contains an elastic structure having a plurality of connected elongated elements located and configured to determine opposed working surfaces to provide support for the urinary system;
and a fixing part located in close proximity to the end for insertion and protruding beyond the working part, which contains many connected elongated elements located and configured to expand laterally inside the vagina of the user,
where the elongated elements contain a high modulus polymer with an elastic modulus of at least 2 GPa and a fatigue stress (t = 50 hours and 40 ° C) at 3% elongation of at least about 30 MPa. 17. The device according to p. 16, in which the high-modulus polymer has an elongation at the yield strength of at least about 3% and stress after aging (t = 50 hours at 40 ° C) at 3% elongation of at least about 35 MPa. 18. The device according to p. 17, in which the high-modulus polymer has a stress after aging (t = 50 hours at 40 ° C) at 3% elongation of at least about 50 MPa. 19. The device according to claim 1, further comprising an outer layer of material that at least partially covers the outer surface of the frame. 20. The device according to claim 1, additionally containing a flexible shell, which essentially covers the frame. 21. The device according to claim 1, in which the working part has an initial equivalent diameter in the range of from about 20 to about 60 mm, an equivalent diameter when introduced in the range of from about 10 to about 25 mm, and a length in the range of from about 10 to about 50 mm . 22. The device according to p. 21, in which the fixing part has an initial equivalent diameter greater than the initial equivalent diameter of the working part.

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